Tag: DTC

DTC

Regulatory/FDA

Current FDA Voluntary Pre-Publication Rx Ad Review Processes

Current FDA Voluntary Pre-Publication Rx Ad Review Processes

As run-up to FDA’s DTC Prescription Advertising Rule that goes into effect on May 20, 2024, CHC is working with FDA staff to help reinforce current ad review processes available to healthcare marketers and how review of ads will change in May and later this year with its November enforcement date. Watch for our planned […]

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Regulatory/FDA

FDA Issues Long-Awaited Final Rule for DTC Prescription Drug Ads

FDA Issues Long-Awaited Final Rule for DTC Prescription Drug Ads

The FDA’s final rule for Direct-to-Consumer Prescription Drug Advertisements (released on November 21, 2023) will certainly impact the creative decisions agencies will make about how to structure the agency refers to as the “major statement” or the dual modality of presenting in a balanced or “neutral” manner the drug’s benefits and risks in visually clear, […]

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Regulatory/FDA

OPDP to Study Risk/Benefit Tradeoff Decisions Made by Consumers, Physicians

OPDP to Study Risk/Benefit Tradeoff Decisions Made by Consumers, Physicians

May 31, 2022 – Understanding the tradeoffs among desirable and undesirable drug product characteristics that consumers and their treating physicians make “will provide valuable insight into the relevance and impact of various product attributes and promotional claims on informed choices and treatment decisions,” according to the Food and Drug Administration’s Office of Prescription Drug Promotion […]

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CHC Comment to FDA: Less Is More in DTC TV Ads

May 2, 2014 – The Coalition for Healthcare Communication believes that “shorter, simpler disclosures are most likely to lead to robust doctor-patient conversations and better health outcomes,” according to a comment the CHC submitted to the FDA today on its proposal to conduct research on the impact of limiting risks presented in direct-to-consumer (DTC) prescription […]

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Drug Facts Literature Review: Call for Comments

Feb. 3, 2012 – There are just 10 days left to comment on an FDA draft report that explores the best way to present risk and benefit information in prescription drug ads. The draft report, “Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review,” which was made public at the end of […]

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Digital Advertising Alliance Launches Consumer Education Campaign

Jan. 27, 2012 – The Digital Advertising Alliance (DAA) last week launched its “Your AdChoices” public education campaign to inform consumers about interest-based advertising and how to take greater control of their online privacy. This campaign follows several years of work by industry association leaders to develop and implement cross-industry best practices and effective solutions […]

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FDA Issues Draft Guidance on Unsolicited Off-label Info Requests, Addresses both Professional and Internet Media

Jan. 2, 2012 – In the waning days of 2011, the FDA released a significant draft guidance on company responses to unsolicited requests for off-label information by healthcare professionals and consumers.  Although the FDA explicitly recognized the value of company-provided information, the draft guidance  adhered to its traditional policy stance strickly limiting such answers to the individual making the request […]

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